MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635TU70040
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sheath damage occurred.A left atrial appendage (laa) closure procedure was being performed.An anterior curve watchman truseal access system (was) was positioned and a 27mm watchman flx laa closure device & delivery system (wds) were used.After a partial recapture of the closure device and repositioning to the proper location, a polytetrafluoroethylene (ptfe) filament from the was noted post release criteria confirmation.The closure device was successfully released into the laa.No patient complications were noted.The patient was discharged home the following day.
Event or Problem Description
It was reported that sheath damage occurred.A left atrial appendage (laa) closure procedure was being performed.An anterior curve watchman truseal access system (was) was positioned and a 27mm watchman flx laa closure device & delivery system (wds) were used.After a partial recapture or the closure device and repositioning to the proper location, a polytetrafluoroethylene (ptfe) filament from the was noted post release criteria confirmation.The closure device was successfully released into the laa.No patient complications were noted.The patient was discharged home the following day.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a watchman truseal access system without the dilator and blood in the device.A watchman delivery system (wds) was returned inside the watchman truseal access system.The tip, sheath and hub were microscopically, tactually, and visually inspected.There was no damage or defects found on the device.The device was cross sectioned (the sheath was cut open) to identify any delaminating polytetrafluoroethylene (ptfe) from the inside of the sheath.There was no ptfe delaminating.Product analysis could not confirm the reported ptfe filamentous material as there was no damage or ptfe delaminating from inside the sheath.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12578533
• Report Number: 2134265-2021-12348
• Device Sequence Number: 19110710
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2024
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0027584009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14F COOK SHEATH; WATCHMAN FLX DELIVERY SYSTEM
• Patient Sex: Unknown